FDA.reportPublic FDA data

SOLOPASS 2.0 Ultrasound Cable Assembly

Primary DI
00860012211913
Brand
SOLOPASS 2.0 Ultrasound Cable Assembly
Company
inTRAvent Medical Partners, L.P.
Model
1
Catalog number
CAB25-0000
Device description
Ultrasound Cable Assembly includes the probe tip, handle assembly and a connector.
Published
2025-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251317000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251317000SOLOPASS 2.0 SystemIntravent Medical Partners2025-09-05HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012211913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012211913008600122119138600122119130860012211913

GMDN Terms#

Term, Definition table
TermDefinition
Neurological stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Sterilization Methods#

Method table
Method
Hydrogen Peroxide

Contacts#

Phone, Email table
PhoneEmail
999-999-9999quality@intraventmedical.com

Regulatory Flags#

DUNS number
052770186
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860012211906SOLOPASS 2.0 Patient Interface Device1PID50-50022025-12-11
00860012211920SOLOPASS 2.0 Workstation1CRT30-00002025-12-11

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